© CDISC 2014 1 CDISC Essential Standards to Enable Learning (ESTEL) Rebecca D. Kush, PhD President and CEO IOM Digital Learning Collaborative: EHRs and Research 30 May 2014
© CDISC 2014 1
CDISC Essential Standards to Enable
Learning (ESTEL)
Rebecca D. Kush, PhD
President and CEO
IOM Digital Learning Collaborative: EHRs and Research
30 May 2014
© CDISC 2012
Research findings to inform
healthcare decisions
Information from healthcare (private, aggregated)
to enable research
•Discovery of new therapies •Understanding diseases •Testing/comparing therapies (CER) •Assessing efficacy •Monitoring safety •Understanding responses (genomics, biomarkers) •Public health/quality evaluations •Post-marketing surveillance
•Quality healthcare •Informed decisions •Personalized medicine •Patient safety and privacy •Public health •Improved therapies •Efficiencies/reduced costs
Research Healthcare
Currently
Inefficient
~17-year cycle
A National-Scale Learning Health System:
Background from the Institute of Medicine
of the National Academies
© CDISC 2014
National LHS: One Infrastructure that Supports • Research
Clinical
Comparative effectiveness
Translational
• Public Health
Surveillance
Situational Awareness
• Quality Improvement
Health process and outcomes
research
Best practice dissemination
• Consumer Engagement
Knowledge-driven decision making
Source: Dr. Charles Friedman
© CDISC 2014
Learning Health Community
• Infrastructure can enable
necessary virtuous cycle of
study, learning and
improvement
• This requires assembly of data,
analysis, and feedback
Assemble Change
Interpret
Analyze Feedback
CORE VALUES
• Person-focused
• Privacy
• Inclusiveness
• Transparency
• Accessibility
• Governance
• Cooperative and
Participatory Leadership
• Scientific Integrity
• Value
© CDISC 2014
6
© CDISC 2014
The Learning Health Community
• Grew out of the 2012 “Learning Health Summit”
• A self-organizing, multi-stakeholder coalition of the willing
• 60 “endorsers” plus > 600 others expressing interest
• “Summit” Planning Committee became the Community’s
Coordinating Committee
• Catalyzing, leading, and participating in initiatives to
realize a Learning Health System
- Standards (ESTEL)
- Governance
- Technology
© CDISC 2012
Essential Standards to Enable
Learning (ESTEL) Charter
Purpose and Scope:
To define a parsimonious/essential/minimum core set of
standards that could enable a standards-based yet flexible and
scalable LHS in accordance with the following goals:
• a) Ease the burden for any clinician to participate in a research
study or other learning activity;
• b) Increase the capacity for learning from data;
• c) Obtain knowledge and results in an actionable form to
contribute to building the LHS;
• d) Ensure that the data obtained can be readily aggregated
and/or compared; and
• e) Ensure that the data uphold scientific integrity.
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~ December 2012
© CDISC 2012
Activities to Date Relative to ESTEL
• May 2012 – Learning Health Community Summit
• Q4 2013 – ESTEL Name and Charter
• February 2013 – ESTEL Launch @ CDISC Office
• March 2013 – ESTEL Webinar
• July 2013 – ESTEL “Exec” Group @ IOM
• September 2013 – Second ESTEL F2F @ Duke
• Oct 2013 – March 2014 - Teleconferences
• April 2014 – Third ESTEL F2F @ AHRQ
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© CDISC 2012
Opportunities/Initiatives to Inform ESTEL
• eSource Data Interchange (eSDI) Initiative – defined
requirements (12) for using eSource (i.e. entering data
electronically - including EHRs, eDiaries) in regulated
research studies (~2006)
• eSource Guidance released by EMA (2010) and FDA
(2013)
• CDISC Healthcare Link Initiative; IHE QRPH Group
• U.S. Health and Human Services (HHS/ONC) HITSP
Interoperability Specification – IS#158 (2009-2010)
• HHS/ONC) Structured Data Capture (SDC) Initiative
(2013-present)
• EU Innovative Medicines Initiative (IMI) EHR4CR and
TRANSFoRm
10
© 2012
ASTER (AE Reporting from EHRs)
30 Ambulatory care physicians at Harvard
and Brigham and Women’s
with Pfizer, CDISC, CRIX
Nov 08 – Jun 09, > 200 Reports Sent to FDA
Physician Reporting:
*91% of participating physicians had
submitted no ADE reports in the prior year
*During the study, participants reported an
average of approximately 5 reports in a 3
month time period
*All participants reported at least 1 AD
* Process: Time to report decreased from
~35 min to < 1 min
Source: Michael Ibara, Pfizer
© CDISC 2012
The “S” Word
What is a standard? • A reference to quality
• An average cut of beef
• In the world of data and technology, there are ‘so many to
choose from’! And, there are many types of standards.
A standard is NOT proprietary.
A standard is NOT a “one-off”.
Standards are developed through a robust, authorized,
consensus-based process and maintained by a
recognized standards development organization (SDO).
True standards are mature, useful and broadly adopted.
Standards do NOT inhibit creativity, rather encourage
innovation.
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Standard
ESTEL Launch – February 2013
© CDISC 2012
Standards and the Learning Health System
13
Essential
Standards
Standards-based
Tool Innovation
The Whole System is
Chaordic, Unmanaged,
approaching Ultra-Large Scale
The Essential Standards
lie between the
Whole System and the Tooling
The Tools come from a
Standards-driven
Innovation Marketplace
ESTEL Exec Group – July 2013
© CDISC 2012
The Hourglass Model
The narrow neck of the hourglass defines
a small set of core abstractions and
protocols (e.g. TCP and HTTP) onto
which many different high-level behaviors
can be mapped (the top of the
hourglass), and which themselves can be
mapped onto many different underlying
technologies (the base of the hourglass).
By definition the number of protocols
defined at the neck must be small.
The Anatomy of the Grid, Kesselman
14
15
The Neck Resource & connectivity
protocols.
The Collective “A wide range of global services
and application-specific
behaviors”
Fabric “Diverse range of resource
types.”
ESTEL
Tools
Healthcare Data
The Hourglass Model: LHS-ESTEL
LHS
ESTEL Meeting – September 2013
April 2014 ESTEL Meeting: Discussed
Standards Requirements and ‘Who?’, ‘What?’
and ‘How?’ relative to the Hourglass Model.
Next Step: What are the Essential Standards
for the LHS---Quality, Research, Public Health,
Consumer Engagement?
© CDISC 2014
TODAY: Research and Healthcare
Medical
Records
(Source
Documents:
Paper or
EHR)
Healthcare Delivery Medical Research
CRFs
(Paper
or
eCRFs)
Data re-entry/transcription
© CDISC 2014
CDISC Healthcare Link
Goal: Optimize the Process
Auto-
Reconciliation for
Source Data Verification
(e)CRFs Source
Documents
EHR
eSource
Healthcare Delivery
~1997
Medical Research
© CDISC 2014
Leveraging Existing Standards at the
Intersection of Healthcare and Research
• Standards FIT FOR PURPOSE, working together
synergistically
• Biomedical Research Integrated Domain Group Model
(BRIDG) (2003-Present) Collaborative, with key stakeholders: NCI, CDISC, HL7, FDA
www.bridgmodel.org
• IHE Profiles for Clinical Research – CDISC Healthcare Link
Developed through the Quality, Research and Public Health (QRPH)
Group with CDISC Leadership
Include Retrieve Form for Data Capture RFD), Research Matching (RM),
Retrieve Process (Protocol) for Execution (RPE), Data Exchange (DEX)
and others
• HL7 Continuity of Care Document (CCDA)->FIHR?
• CDISC Global Clinical Research Standards
Endorsed and/or to be required by FDA and PMDA
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© CDISC 2014 19
© CDISC 2014
Synergistic Standards Available
eCRFs eSource
Documents
EHR
Healthcare Delivery
2014
Medical Research
ODM
HL7 CCDA
Integration
Profiles
(e.g. RFD)
© 2012
Portal,
Views
Analysis
Tools
and/or
Database
EDC
EHR
Data Sources
Care and/or Research Site (Healthcare Location,
Investigator, Site Personnel)
Study Sponsor
(e.g. ARO, CRO, Vendor, Principal Investigator,
federal agencies…)
Structured,
Pseudony-
mized
Research
Datasets &
Tables OR
Patient-level
data
EHR “A” Site
Research
Archive
CCD
EHR “B”
RFD
CCD RFD
EDC
PRO
eDiary
Potential for Staged Implementation of
Standards-based EHRs for Research
© CDISC 2012
Research findings to inform
healthcare decisions
Information from healthcare (private, aggregated)
to enable research
•Discovery of new therapies •Understanding diseases •Testing/comparing therapies (CER) •Assessing efficacy •Monitoring safety •Understanding responses (genomics, biomarkers) •Public health/quality evaluations •Post-marketing surveillance
•Quality healthcare •Informed decisions •Personalized medicine •Patient safety and privacy •Public health •Improved therapies •Efficiencies/reduced costs
Research Healthcare
To reduce
~17-year cycle and
Enable the LHS for
Research:
Technology
Workflow Enablers
Regulatory Encouragement
Synergistic Standards
Business Case
Staged Implementation
Demos and Pilots
WHAT IS MISSING for
THE REAL THING???
© 2012
• What are the remaining barriers?
• How can we remove these?
• How can we accelerate
Standards-Based EHR-enabled Research?